Duns Number:809555139
Device Description: Barraquer lid speculum, .035" Stainless Wire, This design is intended to lay over the temp Barraquer lid speculum, .035" Stainless Wire, This design is intended to lay over the temporal, 14mm Closed square blades, 18mm Blade spread, 39mm total length, Stainless
Catalog Number
W65-14
Brand Name
Diamatrix
Version/Model Number
W65-14
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HNC
Product Code Name
Specula, Ophthalmic
Public Device Record Key
d78873ef-e98e-46e7-9e71-1d9cb188f678
Public Version Date
September 23, 2020
Public Version Number
1
DI Record Publish Date
September 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 475 |
| U | Unclassified | 13 |